QPQuandary
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Posts Tagged Qualified Person

The beginning of the end for the UK QP?

How is your Annex 16 implementation going? Let us know by taking our survey: https://is.gd/zs9y64 What does new Annex 16 require of Pharmaceutical companies and Qualified Persons? Is the risk of being a QP in the UK now more than most people want to contemplate? The results

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Is Germany moving toward a UK style QP study guide?

Is Germany moving toward a UK style QP study guide?

In the UK there is evidence of a shortage of Qualified Persons with pharmaceutical companies finding it difficult to find suitable candidates to fill vacancies.  With many of the original raft of Transitional QPs retiring and only approx. 30 new QPs joining the registers through the UK

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Big Changes Ahead for EU Medical Device Legislation

Big Changes Ahead for EU Medical Device Legislation

“Well what has that to do with me?” you say “I’m a medicinal product QP, Devices don’t need a QP and I don’t need to do any checks on them under the rules and guidelines relevant to my area of responsibility,” OK, so the medicinal product QP

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Latest QP Question

What are the requirements for unlicensed medicinal products in the UK, do you need QP certification? Where would you find guidance?

Latest QP Scenario Practice

Iron Oxide - used as an excipient in many of your products. You find that the supplier has been irradiating the material without your knowledge. What implication does this have for your product? What does this mean for the effectiveness of your supplier oversight and PQS?

Testimonials

"The knowledge, guidance and advice provided by Alex was excellent. Alex has first hand knowledge of the requirements needed for candidates to be successful QPs and provides a level of training to meet these requirements. I can highly recommend QPQuandry as a service provider"
Alex Hern, Sanofi.

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Contact Information

20 Playfield Close, Biggleswade, Bedfordshire, SG18 8JL
Phone: 07813 677741
Website: http://www.qpquandary.co.uk
Email: alex@qpquandary.com"